Mr. Bill Wiederseim has been a consultant to the pharmaceutical, chemical and automotive industries for more than twenty years. He is the co-founder and First Executive Director of The Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP), a non-profit research consortium for the Pharmaceutical Industry, MIT and Purdue University. Mr. Wiederseim is the founder and primary person responsible for the overall development of PharmaBioSource.
Mr. McKee has over 25 years of experience in the pharmaceutical industry with proven success in scientific research and operations. He has significant experience in managing large capital projects with regard to planning, designing and construction in a variety of new laboratory facilities valued at over $850MM. Mr. McKee also has significant experience in the divestment and acquisition of pharmaceutical and biologics manufacturing and laboratory facilities and has performed an extensive number of due diligence surveys. Mr. McKee holds a Bachelor of Science degree in Medicinal Chemistry from Ursinus College.
Mr. Shafran’s Life Sciences career at Pfizer spanned 37 years in diverse roles, and he retired as Vice President of Strategic Planning for Pfizer’s Global Manufacturing Division. His career includes line production management, the management of Pfizer’ s US engineering operations, leadership of Pfizer’s Global Manufacturing IT organization and, for the last ten years, the leadership of Global Manufacturing’s strategic planning activities. In this role, his responsibilities included management of the integration of the Warner-Lambert and Pharmacia manufacturing networks into the Pfizer plant network and the subsequent divestiture of surplus manufacturing sites, and active participation on the corporate acquisition and divestiture teams for the many businesses that Pfizer acquired or sold. Mr. Shafran holds BS and M.Eng. degrees in Chemical Engineering from Cornell University and an MBA from the University of Connecticut.
Ms. Suurkask has strong life sciences strategic and operational consulting experience. Past projects include strategic planning, market assessments, and medical product development and commercialization. Ms. Suurkask holds a Bachelor of Arts in Biology from Harvard University, a Master of BioScience from Keck Graduate Institute of Applied Life Sciences and also holds a Regulatory Affairs Certification in medical products from the Regulatory Affairs Professional Society.
Mr. Signore has more than 25 years of experience in the pharmaceutical industry with SmithKline Beecham, Pfizer and Merck. He has served as the President of the International Society for Pharmaceutical Engineers (ISPE) and received the association's Lifetime Achievement Award. Mr Signore is the co-founder of IPS, a fully integrated engineering firm specializing in clean, compliant industries.
Dr. Amin has more than 30 years of experience in the pharmaceutical industry with experience at The Upjohn Co., Pharmacia and Pfizer. He has held leadership roles in technology and business including Corporate R&D, Global Manufacturing Operations, Global Sourcing and Supply and M&A Integration. He is an advisor to a number of companies in Asia. He holds S.M.,ChE and Sc.D degrees from MIT in chemical engineering.
Mr. Soni has 26 years experience in a broad range of environmental engineering and strategic consulting for industry, the majority of which has been to the pharmaceutical sector. He is widely recognized for his technical and regulatory knowledge in the environmental field, and for guiding clients through environmental compliance in a manner which meets the clients’ business objectives. He is the President and founder of IES. He holds a BS in Chemical Engineering, an MS in Water Resources Engineering, and is a registered Professional Engineer.
Mr. Braithwaite was President and CEO of Accupac (retired), a leading contract manufacturing company serving the Pharmaceutical Industry. Currently, Mr. Braithwaite is the President of PharmaSource Consulting, Inc., a consulting company serving the Pharmaceutical Industry. Mr. Braithwaite is an active member of PharmaBioSource’s Industry Advisory Board.
Mr. Tarantino is a licensed broker with more than 40 years of experience in the Real Estate Industry. He has held many official positions in the real estate industry including member of the Pennsylvania State Real Estate Commission. Mr. Tarantino is also consultant to several banking organizations as well as the Montgomery County (PA) Commissioners and the Pennsylvania Turnpike Commission.
Ms. Morales has more than 15 years of experience in the areas of pharmaceutical technology, quality assurance, and regulatory compliance while maintaining ties with academia via a part-time Visiting Professor appointment at the UPR School of Pharmacy Industrial Pharmacy Program.
Ms. O’Neill has three years of experience within the non-profit industry and five years of progressive experience within the financial services industry, specializing in software application testing. She has been responsible for leading a team of software application testers and mentoring team members by teaching and coaching throughout project life cycle and final release. Ms. O’Neill also has a Bachelor of Science degree in Elementary Education.
Ms. Maurer has over 10 years of experience in the Life Sciences industry. She has broad experience in pharmaceutical research, sales/marketing, database analysis and business plan development. She also holds a Bachelor of Science degree in Biology.
Carl Accettura has 30 years of BioPharma industry experience with both Big Pharma - Pfizer, Roche, BMS as well as Emergent and Virtual Pharma companies – Anesta/Cephalon, RxKinetix, Kyowa Pharmaceuticals, Dainippon Sumitomo Pharma America/Sunovion, and Braeburn Pharmaceuticals. Carl has held executive level positions in the areas of supply chain, new product development and technical operations. He has overseen the development of end-to-end global supply chain strategies and commercial readiness roadmaps for major branded product launches across the US, Europe and Asia. Carl earned a B.S. with distinction from Cornell University in Mechanical Engineering. He holds a M.S. from University of Illinois and a M.B.A from the Stern School at New York University.
Dr. Hensler is a Biochemical Engineer with eighteen years of international cGMP pharmaceutical manufacturing, quality assurance and engineering experience, with particular emphasis on production of bulk biopharmaceuticals including cytokines, monoclonal antibodies, vaccines and blood products. He has extensive knowledge of manufacturing compliance, validation and regulatory requirements for bulk biopharmaceutical facilities according to US FDA, EMEA and ICH regulations (API's and final dosage forms). Dr. Hensler is technically proficient on many aspects of biopharmaceutical processing, with emphasis on large scale bulk production and process validation.
Ms. Niphadkar has solid experience in pharmaceutical and biotechnology strategy consulting and market research. She holds a Bachelor of Engineering in biotechnology from Thadomal Shahani Engineering College (University of Mumbai) with a Master of Science in biotechnology from Texas A&M University.
Mr. Ventura have over 25 years experience in executive management and technical operations in the pharmaceutical industry. Proven leadership in product and process development, process validation, general plant management, facility construction, commissioning and start-up. Extensive technical operations experience with knowledge in manufacturing excellence, Quality by Design/PAT, QA/QC, regulatory/compliance, technology development and transfer, and training. Broad exposure to all aspects of pharmaceutical supply chain management in solid, liquid, and sterile dosage products with extensive lyophilization experience.
Mr. Liu holds a B.Sc. in Materials Science and Industry Trade from Liaoning University of Technology, China and he received his MBA in Pharmaceutical Management from Fairleigh Dickinson University. He has significant experience in the Chinese pharmaceutical market and has extensive regulatory experience. Mr. Liu is fluent in Chinese Mandarin and English.
Mr. Schultz is an information systems specialist with over 15 years experience in the design, implementation and management of corporate information and communication technologies. His experience includes the design, development and implementation of real time barcode inventory and labor reporting systems as well as performing and directing corporate information systems validations to ensure adherence to FDA regulations.
Mr. Zicot is an engineer with a broad range of international experience in the technical aspects of pharmaceutical manufacturing processes - engineering / commissioning / maintenance / optimization / validation. His technical knowledge in the area of production includes: powder processes, IBC's technology, packaging equipment (blisters, bottles, sachets), powder and liquid (aseptic) filling, handling systems, tableting machines, coating, capsuling machines, onguent, blending, granulation, drying (fluid bed dryer, spray dryer, freeze dryer) compaction, sterilization (autoclaves, UV, tunnel), solvent storage, explosion proof (EEX) area, centrifugal dryers, primary chemical plant.
Ms. Schwiegerath is a chemist with more than 20 years of experience in Pharmaceutical R&D analytical research. She has expertise in Analytical Research, method development, method validation, stability testing, raw materials testing and technology transfer to manufacturing. She is also experienced in preparation and editing of IND and NDA submissions to FDA.